*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

Excessive release of inflammatory cytokines due to an uncontrollable immune system (Cytokine Storm) is one of the main causes for autoimmunity and such release of excessive cytokines is also the main driver of severe viral infections leading to Cytokine Release Syndrome (CRS). This project will explore the role of exosomal-cytokine-immune complexes in the pathogenesis of the disease. Exosomes are extracellular vesicles that communicate between cells. The cargo of exosomes includes cytokines involved in CRS and miRNAs and RNA that are biologically active when exported to recipient cells. We hypothesize that in severe cases, when treated with anti-cytokine therapy, it is plausible that the exosomal cytokines form immune complexes with therapeutic antibodies and induce Fc-mediated entry of exosomes, thereby enhancing the pathogenesis of the disease.

Under the guidance of a mentor, the participant will train in classical immunology, molecular biology, and cell biology by characterizing exosomes isolated from various fluids such as cell culture supernatants, serum, plasma and synovial fluid. The participant will also gain knowledge in monoclonal antibody therapies and will be trained on antibody-dependent effector functional assays such as antibody dependent cell-mediated cytotoxicity (ADCC), antibody dependent cell-mediated phagocytosis (ADCP), antibody dependent cell-mediated cytokine secretion, complement dependent cytotoxicity (CDC) and complement dependent cell-mediated cytotoxicity (CDCC) via understanding the exosomal-immune complexes.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.